Overall Response Rate [ Time Frame: From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks. ] [ Designated as safety issue: No ]

Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder.

CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

Secondary Outcome Measures:

Time to Response [ Time Frame: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks. ] [ Designated as safety issue: No ]

Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR).

CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level < 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to < 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.

Duration of Response [ Time Frame: From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks. ] [ Designated as safety issue: No ]

Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.

Progression Free Survival (PFS) [ Time Frame: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks. ] [ Designated as safety issue: No ]

PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.

Overall Survival (OS) [ Time Frame: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months ] [ Designated as safety issue: No ]

The time from the start of study treatment to death due to any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.

Number of Participants With Adverse Events [ Time Frame: From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks ] [ Designated as safety issue: Yes ]

An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.

Hepatitis Bs (HBs) antigen-positive, or hepatitis C virus (HCV) antibody-positive. In case HBc antibody and/or HBs antibody is positive even if HBs antigen-negative, a Hepatitis B virus (HBV) DNA test should be performed and if positive the subject will be excluded.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698801

Locations

Japan

Nagoya City University Hospital

Nagoya, Aichi, Japan, 467-8602

Nagoya Daini Red Cross Hospital

Nagoya, Aichi, Japan, 466-8650

Kameda Medical Center

Kamogawa, Chiba, Japan, 296-8602

Japanese Red Cross Narita Hospital

Narita, Chiba, Japan, 286-8523

Ehime University Hospital

Touon, Ehime, Japan, 791-0295

Nishigunma National Hospital

Shibukawa, Gunma, Japan, 377-8511

Kobe City Medical Center General Hospital

Kobe, Hyogo, Japan, 650-0047

Hitachi General Hospital

Hitachi, Ibaraki, Japan, 317-0077

Iwate Medical University

Morioka, Iwate, Japan, 020-8505

Tokai University Hospital

Isehara, Kanagawa, Japan, 259-1193

Tohoku University Hospital

Sendai, Miyagi, Japan, 980-8574

Kurashiki Central Hospital

Kurashiki, Okayama, Japan, 710-8602

Kinki University Hospital, Faculty of Medicine

Osakasayama, Osaka, Japan, 589-8511

Shizuoka Cancer Center

Sunto, Shizuoka, Japan, 411-8777

National Disaster Medical Center

Tachikawa, Tokyo, Japan, 190-0014

Kagoshima Medical Center

Kagoshima, Japan, 892-0853

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, Japan, 602-8566

Niigata Cancer Center Hospital

Niigata, Japan, 951-8566

Okayama Medical Center

Okayama, Japan, 701-1192

Osaka Red Cross Hospital

Osaka, Japan, 543-8555

Japanese Red Cross Medical Center

Tokyo, Japan, 150-8935

Keio University Hospital

Tokyo, Japan, 160-8582

National Cancer Center Hospital

Tokyo, Japan, 104-0045

The Cancer Institute Hospital of Japanese Foundation for Cancer Research